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New Pediatric Labeling Information Database - Detail
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Pediatrics
New Pediatric Labeling Information Database
Detail
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Pediatric Labeling Date:
03/31/2016
Trade Name:
Lumason
Generic Name or Proper Name (*):
Sulfur Hexafluoride Lipid-Type A Microspheres
Indications Studied:
Ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients
Label Changes Summary:
* Effectiveness in pediatric patients has been established for use in ultrasonography of the liver for characterization of focal liver lesions from adequate and well controlled trials in adult patients and a clinical study of 44 pediatric patients. Safety was based on evaluation of published literature involving use of Lumason in over 900 pediatric patients. Non-fatal anaphylaxis was reported in one pediatric patient. * New indication
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Bracco Diagnostics
NNPS:
FALSE
Therapeutic Category:
Medical Imaging
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